Thursday, September 14, 2006

A very positive, recent development in our laws is the promulgation into law of Republic Act 9288 or the Newborn Screening Act of 2004. You can find the complete text of RA 9288 in my website www.familymatters.org.ph. Below is a primer on this law.

What is Republic Act No. 9288? It is the Philippine law promulgating a comprehensive policy and a national system for ensuring newborn screening. RA 9288 is known as the "Newborn Screening Act of 2004." It was approved on April 07, 2004.

What is the policy of the State with regards the health of the people, especially children?

It is the policy of the State to protect and promote the right to health of the people, including the rights of children to survival and full and healthy development as normal individuals.In pursuit of such policy, the State through RA 9288 has institutionalized a national newborn screening system that is comprehensive, integrative and sustainable, and will facilitate collaboration among government and non-government agencies at the national and local levels, the private sector, families and communities, professional health organizations, academic institutions, and non-governmental organizations.

The National Newborn Screening System shall ensure that every baby born in the Philippines is offered the opportunity to undergo newborn screening and thus be spared from heritable conditions that can lead to mental retardation and death if undetected and untreated.

What are the objectives of the National Newborn Screening System?

[1] To ensure that every newborn has access to newborn screening for certain heritable conditions that can result in mental retardation, serious health complications or death if left undetected and untreated;

[2] To establish and integrate a sustainable newborn screening system within the public health delivery system;

[3] To ensure that all health practitioners are aware of the advantages of newborn screening and of their respective responsibilities in offering newborns the opportunity to undergo newborn screening; and

[4] To ensure that parents recognize their responsibility in promoting their child’s right to health and full development, within the context of responsible parenthood, by protecting their child from preventable causes of disability and death through newborn screening.

What is meant by Comprehensive Newborn Screening System?

It means a newborn screening system that includes, but is not limited to,

[1] Education of relevant stakeholders; collection and biochemical screening of blood samples taken from newborns;

[2] Tracking and confirmatory testing to ensure the accuracy of screening results; clinical evaluation and biochemical/medical confirmation of test results;

[3] Drugs and medical/surgical management and dietary supplementation to address the heritable conditions; and

[4] Evaluation activities to assess long term outcome, patient compliance and quality assurance.

What is meant by “follow-up” in the context of RA 9288?

Follow-up means the monitoring of a newborn with a heritable condition for the purpose of ensuring that the newborn patient complies fully with the medicine of dietary prescriptions.

What are included under the term “health institutions”?

The term includes hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private.

It means any condition that can result in mental retardation, physical deformity or death if left undetected and untreated and which is usually inherited from the genes of either or both biological parents of the newborn.

What is meant by “newborn?”

“Newborn” means a child from the time of complete delivery to 30 days old.

What is “newborn screening”?

It means the process of collecting a few drops of blood from the newborn onto an appropriate collection card and performing biochemical testing for determining if the newborn has a heritable condition.

What is a Newborn Screening Center?

It is a facility equipped with a newborn screening laboratory that complies with the standards established by the NIH and provides all required laboratory tests and recall/follow-up programs for newborns with heritable conditions.

What is the Newborn Screening Reference Center?

It is the central facility at the NIH that defines testing and follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training activities in all aspects of the program, oversees content of educational materials and acts as the Secretariat of the Advisory Committee on Newborn Screening.

What is meant by “parent education?”

It refers to the various means of providing parents or legal guardians information about newborn screening.

What is meant by “recall”?

“Recall” means a procedure for locating a newborn with a possible heritable condition for purposes of providing the newborn with appropriate laboratory to confirm the diagnosis and, as appropriate, provide treatment.

What will treatment consist of a newborn is found to have a heritable condition?

Treatment means prompt, appropriate and adequate medicine, medical, and surgical management or dietary prescription to a newborn for purposes of treating or mitigating the adverse health consequences of the heritable condition.

What are the obligations of health practitioners under RA 9288?

Any health practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall, prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of newborn screening. Appropriate notification and education regarding this obligation shall be the responsibility of the Department of Health (DOH).

How is newborn screening performed?

Newborn screening shall be performed after twenty-four (24) hours of life but not later than three (3) days from complete delivery of the newborn. A newborn that must be placed in intensive care in order to ensure survival may be exempted from the 3-day requirement but must be tested by seven (7) days of age.

It shall be the joint responsibility of the parent(s) and the practitioner or other person delivering the newborn to ensure that newborn screening is performed. An appropriate informational brochure for parents to assist in fulfilling this responsibility shall be made available by the Department of Health and shall be distributed to all health institutions and made available to any health practitioner requesting it for appropriate distribution.

Can parents refuse to have their babies tested?

A parent or legal guardian may refuse testing on the grounds of religious beliefs, but shall acknowledge in writing their understanding that refusal for testing places their newborn at risk for undiagnosed heritable conditions. A copy of this refusal documentation shall be made part of the newborn’s medical record and refusal shall be indicated in the national newborn screening database.

What are the requirements of RA 9288 for health institutions?

The DOH and the Philippine Health Insurance Corporation (PHIC) shall require health institutions to provide newborn screening services as a condition for licensure or accreditation.

What are the procedures or requirements in the establishment and accreditation of Newborn Screening Centers?

The DOH shall ensure that Newborn Screening Centers are strategically located in order to be accessible to the relevant public and provide services that comply with the standards approved by the Committee upon the recommendation of the NIH. No Newborn Screening Center shall be allowed to operate unless it has been duly accredited by the DOH based on the standards set forth by the Committee.

At a minimum, every Newborn Screening Center shall: (i) have a certified laboratory performing all tests included in the newborn screening program, (ii) have a recall/follow up programs for infants found positive for any and all of the heritable conditions; (iii) be supervised and staffed by trained personnel who have been duly qualified by the NIH; and (iv) submit to periodic announced or unannounced inspections by the Reference Center in order to evaluate and ensure quality Newborn Screening Center performance.

What is the Newborn Screening Reference Center and what is its function?

The NIH shall establish a Newborn Screening Reference Center, which shall be responsible for the national testing database and case registries, training, technical assistance and continuing education for laboratory staff in all Newborn Screening Centers.

The NIH Newborn Screening Reference Center shall be responsible for drafting and ensuring good laboratory practice standards for newborn screening centers, including establishing an external laboratory proficiency testing and certification program. It shall also act as the principal repository of technical information relating to newborn screening standards and practices, and shall provide technical assistance to newborn screening centers needing such assistance.

What is required of all Newborn Screening Centers?

They must coordinate with the NIH Newborn Screening Reference Center for consolidation of patient databases. The NIH Newborn Screening Reference Center shall maintain a national database of patients tested and a registry for each condition. It shall submit reports annually to the Committee and to the DOH on the status of and relevant health information derived from the database.

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